The Inflation Reduction Act of 2022 (the “IRA”) includes several provisions that may impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay the rebate rule that would limit the fees that pharmacy benefit managers can charge.
All entries for: Neurological Diseases
November 5, 2025
Merck
Neutral Outlook
Rahway, NJ
10,001-50,000 employees
In 2022, the U.S. Congress passed the Inflation Reduction Act (IRA), which made significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits (which has taken effect in 2025), and government price-setting for certain Medicare Part D drugs (starting in 2026) and Medicare Part B drugs (starting in 2028).
Disease Area: Antiviral, Cardiology, Immune Diseases, Multiple, Neurological Diseases, Oncology
Drug Type: Biologic, Small Molecule
November 4, 2025
Stoke Therapeutics, Inc.
Neutral Outlook
Bedford, MA
51-200 employees
Healthcare reform initiatives culminated in the enactment of the Inflation Reduction Act (“IRA”) in August 2022, which, among other things, allows U.S. Department of Health and Human Services (“HHS”) to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that the Centers for Medicare & Medicaid Services (“CMS”) reimburses under Medicare Part B and Part D.
Disease Area: Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 4, 2025
Stoke Therapeutics
Neutral Outlook
Bedford, MA
51-200 employees
Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the pharmaceutical industry.
Disease Area: Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 4, 2025
Compass Pathways Plc
Neutral Outlook
London, England
51-200 employees
The Inflation Reduction Act of 2022, or the IRA, for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries to $2,000 starting in 2025, eliminating the prescription drug coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of an HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge
Disease Area: Neurological Diseases, Psychiatry
Drug Type: Small Molecule
November 3, 2025
Solid Biosciences Inc.
Negative Outlook
Boston, MA
51-200 employees
Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.
Disease Area: Cardiology, Multiple, Neurological Diseases, Rare Diseases
Drug Type: Biologic
November 3, 2025
Axsome Therapeutics
Negative Outlook
New York, NY
201-500 employees
We are evaluating what effect, if any, the IRA may have on our business. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs.
Disease Area: Chronic Disease, Neurological Diseases
Drug Type: Small Molecule
October 30, 2025
Bausch Health Companies Inc
Neutral Outlook
Bridgewater, NJ
10,001-50,000 employees
In August 2022, the Inflation Reduction Act (“IRA”) was signed into law, which among other matters made significant changes to how drugs are covered and paid for under the Medicare program, including imposing financial penalties if drug prices are increased at a rate faster than inflation, redesigning Medicare Part D benefits to shift a greater portion of the costs to manufacturers and allowing the U.S. government to set prices for certain drugs in Medicare. The IRA also provides for (i) the U.S. government to set or “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Medicare Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Medicare Part D and 2023 for Medicare Part B drugs and (iii) Medicare Part D redesign which replaces the current Part D Coverage Gap Discount Program and establishes a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases
Drug Type: Small Molecule
October 30, 2025
Bicycle Therapeutics
Negative Outlook
Cambridge, MA
201-500 employees
Our results of operations could be adversely affected by the Patent Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, the Inflation Reduction Act of 2022, or the IRA, and by other healthcare legislative reforms that may be enacted or adopted in the future, particularly in light of the recent U.S. Presidential and Congressional elections. We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
Disease Area: Cardiology, Multiple, Neurological Diseases, Oncology
Drug Type: Small Molecule
October 30, 2025
Vanda Pharmaceuticals
Neutral Outlook
Washington DC
201-500 employees
Prior to January 1, 2025, the Medicare Part D prescription drug benefit required manufacturers to fund approximately 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients for applicable drugs. We account for the Medicare Part D coverage gap using a point of sale model. Estimates for expected Medicare Part D rebates are based, in part, on historical activity and, where available, actual and pending prescriptions when we have validated the insurance benefits.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule